Endo Pharmaceuticals Gives Update On Regulatory Status Of Testosterone Undecanoate For Men With Hypogonadism

Main Category: Endocrinology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 03 Sep 2009 - 3:00 PST

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Endo Pharmaceuticals (Nasdaq: ENDP) announced that it has been informed by the U.S. Food and Drug Administration (FDA) that the agency has extended its review period for its long-acting testosterone undecanoate injection for men diagnosed with hypogonadism, from Sept. 2, 2009 to Dec. 2, 2009.

While the FDA has not requested additional data, the agency has informed the company that it needs more time to complete its review of the application and finalize the risk evaluation and mitigation strategy (REMS) for this product.

"Our goal is to make this significant new treatment option available to the millions of men in the U.S. suffering from low testosterone," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "We believe our application fully supports the approval of this therapy, which will be an important step in filling a gap in testosterone therapy and improving patient care."

Endo Pharmaceuticals' long-acting testosterone undecanoate, known as Nebido(R) outside the U.S., was licensed by Bayer Schering Pharma AG, Germany to Indevus Pharmaceuticals, a company that Endo acquired earlier this year. Nebido, discovered and developed by Bayer Schering Pharma AG, Germany, has subsequently been approved in 86 countries worldwide and is available in more than 50 countries across Europe, Asia Pacific and Latin America.

About Hypogonadism

Hypogonadism, or low testosterone, is a common yet largely under-recognized and under-treated condition. An estimated 13.8 million American men have testosterone levels characterized as below normal (testosterone <300ng/dl). Yet despite this high prevalence, only about 9 percent of men with low testosterone are treated with testosterone replacement therapy.

Low testosterone is associated with a broad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, there is increasing evidence of the link between low testosterone and other serious medical conditions including diabetes, cardiovascular disease and metabolic syndrome.

About Endo

Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; Percocet(R) and Percodan(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; Voltaren(R) Gel, which is owned and licensed by Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees; SANCTURA(R) and its XR version for treatment of overactive bladder; VANTAS(R) for the palliative treatment of advanced prostate cancer; and SUPPRELIN(R) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the company's financial position, results of operations, market position, product development and business strategy, as well as estimates of future net sales, future expenses, future net income and future earnings per share. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "intend," "guidance" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this press release. These factors include, but are not limited to those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K, particularly the discussion under the caption "Item 1A, RISK FACTORS" in our annual report on Form 10-K for the year ended December 31, 2008, which was filed with the Securities and Exchange Commission on March 2, 2009. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, we think could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Source: Endo Pharmaceuticals

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